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The final contract awarded under the Master Agreement mechanism was made in 2002. Studies funded under the MA mechanism are ongoing and will be supported through completion.

The DCP Study Site Monitoring Manual is the main clinical trials management resource for MA investigators.

The SSMM is available in PDF only.

Entire Study Site Monitoring Manual - Division of Cancer Prevention (DCP) Study Site Monitoring Manual - August 2007 (pdf, 859kb)

Study Site Monitoring Manual Table of Contents

• Chapter 1 - Introduction (pdf, 30kb)
• Chapter 2 - DCP Organizational Overview, Description of Prevention Trials and Summary of Contractor Responsibilities (pdf, 35kb)
• Chapter 3 - DCP Study Staff Roles and Responsibilities (pdf, 43kb)
• Chapter 4 - Participant Enrollment (pdf, 41kb)
• Chapter 5 - Study Record Maintenance (pdf, 46kb)
• Chapter 6 - Serious Adverse Event Reporting (pdf, 44kb)
• Chapter 7 - Protocol Deviation Reporting (pdf, 35kb)
• Chapter 8 - Change in Participant Status (pdf, 32kb)
• Chapter 9 - Site Monitoring by Westat/DCP Monitoring Contractor (pdf, 51kb)
• Appendix A - Accessing the Division of Cancer Prevention, DCP Monitoring Contractor, and DCP Regulatory Contractor (pdf, 23kb)
• Appendix B - Glossary of Terms (pdf, 55kb)
• Appendix C - Form FDA 1572 (pdf, 244kb)
• Appendix D - Protocol Deviation Notification (pdf, 13kb)
• Appendix E - Serious Adverse Event Form (pdf, 28kb)
• Appendix F - Initiation Visit Report Forms (pdf, 34kb)
• Appendix G - Annual Visit Report Forms (pdf, 29kb)
• Appendix H - Close-out Visit Report Forms (pdf, 19kb)
• Appendix I - Pharmacy Audit Report Form (pdf, 24kb)
• Appendix J - Essential Documents for the Conduct of a Clinical Trial (pdf, 49kb)
• Appendix K - FDA Financial Disclosure Form 3455 (pdf, 132kb)

For any questions not addressed in the Study Site Monitoring Manual, please contact the Protocol Information Office.